FDA.reportPublic FDA data

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

Product NDC
80641-001
11-digit product format
806410001
Labeler code
80641
Product ID
80641-001_47224083-a029-4253-9660-b228c66263ff
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
25; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE25 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7794831-52d1-4d80-936d-44af18ae0472Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80641-001-012024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-012024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-001-01VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN100 mL in 1 TUBELOTION1008
80641-001-02VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN30 mL in 1 TUBELOTION308
80641-001-03VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN7 mL in 1 PACKETLOTION78
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN177 mL in 1 TUBELOTION1778
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN2 in 1 KITLOTION28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-001VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [VACATION INC.]5Current NDC, Legacy NDC, 5 package rows20250109_c7794831-52d1-4d80-936d-44af18ae0472.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 214 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - WatermelonZINC OXIDEKoco Life LLC3491fb2a-d55f-1736-e063-6294a90a594a2025-05-07WarningsExact identifier
application number: M020
Abib Heartleaf mild sunscreen Relief tubeZINC OXIDEFOURCOMPANY CO., LTD.34965587-c9b7-4066-e063-6394a90ab4242025-05-07WarningsExact identifier
application number: M020
CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins157cb8ca-1a36-41fb-be9e-b157b146dc4d2025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50 SportAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutionse25e4f76-8311-491b-e053-2a95a90a4fc82025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260b901-5918-48df-e053-2a95a90a68c32025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e25cf8e4-93cd-f5f6-e053-2995a90a45452025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30 GallonAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260c1bc-8b79-abc7-e053-2a95a90ae4d22025-05-06WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Pink StrawberryZINC OXIDEKoco Life LLC347e665f-cb59-ab04-e063-6394a90ad0a62025-05-06WarningsExact identifier
application number: M020
Saucd Toasted Golden Tanning SPF 15 CaramelAVOBENZONE, OCTISALATE, HOMOSALATESAUCD GENERAL TRADING COMPANYe10d41cd-e03e-401c-9024-263350b3ec2a2025-05-05WarningsExact identifier
application number: M020
Visor Clear Body Mist Hydrating Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLCb2d7639c-cbfb-4127-8ee4-7355e0d021e12025-05-05WarningsExact identifier
application number: M020
Jacket Ultimate Performance Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSd4d82c41-01da-40af-a22c-d4d57af7a2f22025-05-05WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Butter Stick SPF 50ZINC OXIDEElemental Herbs, Inc.114c6ac8-b133-cd16-e063-6294a90ac4f92025-05-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80641-001-0180641000101100 mL in 1 TUBE (80641-001-01) 100 ml2022-04-060000-00-00NoNoCurrent
80641-001-028064100010230 mL in 1 TUBE (80641-001-02) 30 ml2022-04-060000-00-00NoNoCurrent
80641-001-03806410001037 mL in 1 PACKET (80641-001-03) 7 ml2022-04-060000-00-00NoNoCurrent
80641-001-04806410001042 TUBE in 1 KIT (80641-001-04) / 177 mL in 1 TUBE2 tube2024-03-01NoNoCurrent